WO2009145741A2 - Phosphate de calcium enrobant du ti<sb>6</sb>al<sb>4</sb>v avec une solution de liquide corporel tamponnée avec du lactate de sodium et de l’acide lactique - Google Patents

Phosphate de calcium enrobant du ti<sb>6</sb>al<sb>4</sb>v avec une solution de liquide corporel tamponnée avec du lactate de sodium et de l’acide lactique Download PDF

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WO2009145741A2
WO2009145741A2 PCT/TR2009/000052 TR2009000052W WO2009145741A2 WO 2009145741 A2 WO2009145741 A2 WO 2009145741A2 TR 2009000052 W TR2009000052 W TR 2009000052W WO 2009145741 A2 WO2009145741 A2 WO 2009145741A2
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coating
preceeding
sbf
naoh
cap
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WO2009145741A3 (fr
Inventor
Ahmet Pasinli
Mithat Yuksel
Hasan Havitcioglu
A. Cuneyt Tas
R. Sami Aksoy
Erdal Celik
Hasan Yildiz
Mustafa Toparli
Ahmet Canatan
Sevil Sener
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/32—Phosphorus-containing materials, e.g. apatite

Definitions

  • the main objective of this study was to investigate hydroxyapatite (HA) and calcium phosphate (CaP) coatings on T ⁇ 6AI4V substrates by using the biomimetic technique.
  • HA hydroxyapatite
  • CaP calcium phosphate
  • the newly formulated body fluid (Lac-SBF) contained appropriate amounts of sodium lactate (NaL) and lactic acid (HL), as well as all the other ionic constituents of the human blood plasma.
  • the inorganic ion concentrations of the Lac- SBF solutions were identical with those of human blood plasma.
  • the new Lac-SBF solution of this study eliminated the need for using Tris/HCI or Hepes/NaOH buffers.
  • the substrates Prior to coating process, the substrates were chemically treated in NaOH and NaOH+H 2 ⁇ 2 as an alternative route and heat treated at 600 0 C for 1 hour in air.
  • HL/NaL which is generated by human body and do not show any toxic behavior as buffer solution instead of tris/HCI in researches presented in the literature has been marked a new epoch in biomimetic applications. It was determined that adhesion strengths of the coatings are increased in biomimetic results of the performed in-vivo tests.
  • This invention will be presented a great service to man due the fact that the metal implants which are coated with CaP in the Lac-SBF solution are used in living creatures, the implant material is strongly bonded to bond surfaces, and it shortens a patient recovery period by quickly knitting to bones. This case is understood via better bonding of CaP coated anchor screws to bone in a demonstration of biomimetic results.
  • Titanium alloy (Ti6AI4V) is a material which is commonly used in the manufacturing of orthopedic implants such as hip prostheses, bone plates and bone screws.
  • the excellent mechanical properties, low density and inert nature of this material made it desirable for restoring the structural integrity of hard tissues that have undergone physical or pathogen-related trauma.
  • the non-corrosive nature of titanium has many biological benefits.
  • Commercially pure titanium and Ti6AI4V do not induce a negative immune response from the body and exhibit very low incidence of toxicity and rejection. Nevertheless, this same lack of interaction with the biological environment partially prevents the implant from integrating with the surrounding hard tissue (L. L. Hench, J. Am. Ceram. So ⁇ , 1991, 74, 1487-1510).
  • CaP coatings such as hydroxyapatite [Ca 5 (PO 4 ) 3 (OH)] have been used on orthopedic implants (H. Li, et al. , Mater. Sci. Eng. C, 2007, 27, 756-761; T. Kokubo, et. al., J. Mater. Sci. Mater. M., 2004, 15, 99-107; A. Bigi, et. al., Biomaterials, 2005, 26, 4085-4089).
  • the addition of this bioceramic to the surface of oxidized metallic implants has been shown to dramatically enhance the hard tissue integration, thereby increasing the in-situ mechanical stabilization (M. Demircioglu, et. al., Key Eng.
  • Biocompetable materials are considered to be the most important feature in biomaterials, allow the surrounding tissue to differentiate normally and preventing undesired reactions such as infection and blood clot. Due to these requirements, in- situ biomimetic coating method generally is chosen for these applications.
  • the apatite-like CaP coating is achieved by placing the substrates to be coated into a simple biocompatible aqueous medium kept at the body temperature of 37 0 C and at the blood pH of 7.4 (T. Kokubo, et. al., 2004, J. Mater. Sci. Mater. M., 15, 99-107).
  • the calcification solutions (usually called as SBF) allow the in situ chemical precipitation from a metastable supersaturated solution similar in ion concentrations similar to those of human blood plasma (A. Bigi, et. al., 2005, Biomaterials, 26, 4085-4089)
  • SBF chemical immersion techniques, in which titanium implants are allowed to soak in a solution containing high concentrations of calcium and phosphate for a specified period of time.
  • Bayraktar, A. C. Tas, 1999, J. of The European Ceramic Society, 19, 2573-2579 are the two commonly known Tris-buffered SBFs. The pH values of these solutions were adjusted to 7.4 by using the Tris/HCI pair.
  • Tas and Bhaduri (A.C. Tas et. al., J. Mater. Res., 2004, 19, 2742-2749) had previously shown that it was possible to coat Ti6AI4V substrates at room temperature with an apatite-like CaP layer much more rapidly (in few hours) by using a solution having ten times the concentrations of Ca 2+ and HPO 4 2' ions than present in a typical SBF solution, also without a need for the presence of a buffering agent, such as Tris or Hepes. Later, Bigi et al. (A. Bigi, et. al., 2005, Biomaterials, 26, 4085-4089) also demonstrated a supersaturated calcium phosphate solution, but buffered with Hepes, to maintain the pH in the vicinity of physiological levels.
  • a buffering agent such as Tris or Hepes
  • Lac-SBF solutions precisely matched all of the ion concentrations of the human blood plasma.
  • CaP coatings were formed on T ⁇ 6AI4V substrates by using these novel Lac-SBF solutions.
  • NaOH has been used as an etching fluid of T ⁇ 6AI4V base materials in surface finishing before coating process, but NaOH+H 2 O 2 mixture has not yet used in literature.
  • This invention will be provided a considerable contribution in applications with usage of NaOH+H 2 O 2 mixture which is used in preprocessing of the substrate in application as an etching fluid, and a subsequent preparation of a rough surface which is more proper in a strong adhesion of the coatings to the substrate.
  • FIG. 1 Process steps for formation of CaP phases.
  • Both NaOH and NaOH+H 2 O 2 solutions were used for the chemical etching process to compare their merits after the biomimetic coating.
  • One half of the total substrates were chemically etched in 5 M NaOH aqueous solution at 60°C for 24 h. After adding an appropriate amount of H 2 O 2 solution to a 5 M NaOH solution, the other half of the substrates was chemically treated at 60 0 C for 24 h in the NaOH+H 2 O 2 solution. All the substrates were thoroughly washed with an ample supply of distilled water, followed by drying at 40 0 C for 24 h in air.
  • the etched substrates were finally heat- treated at 600 0 C in a microprocessor-controlled furnace with heating rates of 5°C/min, soaked at 600 0 C for 1 h and were then cooled slowly in the furnace down to room temperature.
  • Lac-SBF was prepared by using the salt amounts given in Table 2. It must be noted that the recipe of Table 2 was for preparing 2.5X Lac-SBF solutions in a total volume of 2500 ml_. In preparing the 2.5X Lac-SBF solutions, only the Ca 2+ and HPO 4 2" ion concentrations were multiplied by a factor of 2.5, with respect to those of human blood plasma. Following the addition of CaCI 2 .2H 2 O and MgCI 2 .6H 2 O into the solution, a total volume of 40 mL of 1 M HL was periodically added into the solution to prevent precipitation.
  • the substrates to be coated were placed in glass containers into a constant- temperature water bath (maintained at 37°C) and the coating time was 48 h at 37°C.
  • Lac-SBFX2.5 solution was fed to the sample containers by a peristaltic pump at the feed rate of 4 mL/h, meaning that the solution was replenished at the stated rate during the entire biomimetic coating period of 48 h at 37°C.
  • the coated samples were taken out of the solution and were washed with distilled water. Finally, the samples were dried at 40°C for 24 h in air. In case of SBFxI and SBFx2.5, only Ca 2+ and PO 4 3" ions were used as once and 2.5 times respectively.
  • the ion concentrations of the Lac-SBF solutions were compared with those of Tris- buffered Kokubo-SBF's (T. Kokubo, et.a al., 1999, Comp. Part A: App. Sci. and Man. 30, 405-409) and Tas-SBF's (A.C. Tas, et. al., 2004, J. of Material Research, 19, 2742-2749) in Table 3.
  • the prepared Lac-SBFx1 was shown similar concentration to human blood plasma in terms of all inorganic ions, which is the first time in the mechanicalture.
  • Equation 1 The ionic strength of the solutions was calculated by using Equation 1.
  • FTIR (Perkin Elmer) absorption spectra of the CaP samples were measured over the range of 4000 cm “1 to 400 cm “1 .
  • TIME TimeSurf For TR200 V1.0
  • Adhesion strength of CaP coatings were determined by using a SHIMADZU Scanning Scratch Tester (SST-W101 Model). Scratch test is carried out to determine and analyze the adhesion strength of the CaP coatings to the substrates.
  • the biomechanical tensile tests were performed by using the testing machine (AG-I 10 kN, Shimadzu, Japanese). The mechanic testing was carried out in room temperature. A static loading was applied to the anchors. Tensile tests were performed to fourteen adult New Zealand white rabbits. Seven animals were used for each group. Seven of them were selected as an uncoated Ti6AI4V anchors (without CaP) called control group. The other seven rabbits were selected as Ti6AI4V anchors coated with CaP. The anchors were pulled-out of the right tibia of the animals. The pull-out tests were performed to the bones at a constant speed of 5mm/mi ⁇ . The bones were fixed to the test machine for stabilization.
  • Turbidimeter is an instrument for measuring the loss in intensity of a light beam shined through a solution that contains suspended particulate matter. Turbidimetric or nephelometric measurements were used to confirm the complete dissolution of powder-based salts in the perfectly transparent solutions.
  • the turbidity values of the Lac-SBF solutions were given in Table 4. Their turbidity values before and after coating process was indicated that powder based chemical precursors was completely dissolved in the solutions. What we want to emphasize here that the difference between two solutions is because Ca 2+ and PO 4 3" ions were consumed in the solutions owing to coating process. However, it can be expressed that no significant change in turbidity values were observed.
  • pH value of such supersaturated solutions is an important factor influencing the solubility, stability and the nucleation-growth of apatite-like CaP phases, and this should be taken into account in preparing solutions.
  • pH value of the Lac-SBF solution should be adjusted close to 7 because precipitation easily forms in the solution when pH value increases (T. Kokubo, et.a al., 1999, Comp. Part A: App. Sci. and Man. 30, 405-409).
  • the pH value of the transparent solution increased from 6.78 to around 8.9. The cause of this pH increase could be explained by the reactions of the HPO 4 2" and HCO 3 " ions in the solution with HL, as seen in Equations 2 and 3 below,
  • HPO 4 2" and HCO 3 " were converted to about 39% H 2 PO 4 " and 76.5% CO 2 , respectively. Since HCO3 " is soluble in water, CO 2 easily formed and escaped off of the solution during the process. Besides, the pH value increase causes a precipitation of Ca, P and CO 3 while preparing solutions. CaP has been deposited on " ⁇ 6AI4V substrates which were chemically cleaned with NaOH ve NaOH+H 2 O 2 by immersing into coating solutions. The pH value increases slightly at the end of the process.
  • the FTIR spectra of the biomimetic CaP coatings formed after 2 days in 2.5X Lac- SBF were given in Fig. 2.
  • a broad phosphate band originating from the P-O asymmetric stretching mode of the phosphate group was found in the region from 1100 to 1000 cm "1 , indicating a deviation of the phosphate ions from their ideal tetrahedral structure.
  • the IR bands detected at 1460-1420 and 875 cm “1 were assigned to the CO 3 2" group of carbonated apatite where the PO 4 3" groups were substituted by CO 3 2" .
  • the absence of the usually sharp vibration band derived from hydroxyl ions at 3500-3700 cm "1 probably indicates the substitution of hydroxyl (OH " ) ions by carbonate ions in the apatite structure.
  • FIG. 3 depicted the XRD traces of CaP coatings obtained on the Ti6AI4V alloy substrates.
  • Ca 5 PO 4 .2H 2 O (apatite) and CaHPO 4 .2H 2 O (brushite), titanium and rutile (TiO 2 ) phases were detected on the coatings obtained on T ⁇ 6AI4V substrates which were chemically treated in NaOH and NaOH+H 2 O 2 .
  • Brushite was the major crystalline phase.
  • the rutile, TiO 2 phase was formed on the Ti6AI4V substrates during their heat treatment at 600 0 C. It was also obvious from Figure 3 that the Ti peak obtained at the 2 ⁇ value of 38.47° corresponded to the (002) plane.
  • Figure 4 showed the adhesion characteristics of the CaP coatings on T ⁇ 6AI4V substrates pretreated in NaOH and NaOH+H 2 O 2 solutions. Scratch testing is normally performed under controlled conditions (increasing load and constant speed or vice versa, or both constant) and by scratching of a coated surface with a specified indenter. A diamond-shaped indenter is usually used and from an exact knowledge of all test parameters, and by measuring the critical load at failure of the coating, the adhesion strength can be estimated (J. Forsgren, et. al., Acta Biomaterialia, 2007, 3, 980-984).
  • CaP coating on metal implant is an effective method to enhance bioactive properties of the metal surface. It improves the bonding strength on bone tissue without inducing the growth of fiber tissue. CaP coating can act as a barrier between the body and the metallic implant, and provide a surface on which bone can easily grow, generating mechanical interlocking and chemical bonding at the bone-implant interface.
  • This invention will present a great service to mankind with using the metal implants which are coated with CaP in the Lac-SBF solution in living creatures, that the implant material is strongly bonded to bond surfaces, and that it shortens a patient recovery period by quickly knitting to bones.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L’invention se rapporte à un procédé d’enrobage biomimétique modifié de surfaces d’implants en TI6Al4V avec du phosphate de calcium (CaP) dans lequel on traite préalablement chimiquement le substrat à revêtir dans du NaOH+H2O2, puis on effectue une synthèse du revêtement (biocéramique) à base de CaP en utilisant la croissance biomimétique dans un liquide corporel simulé (SBF) contenant des quantités appropriées de lactate de sodium (NaL) et d’acide lactique (HL).
PCT/TR2009/000052 2008-05-27 2009-04-24 Phosphate de calcium enrobant du ti<sb>6</sb>al<sb>4</sb>v avec une solution de liquide corporel tamponnée avec du lactate de sodium et de l’acide lactique Ceased WO2009145741A2 (fr)

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EP09755172A EP2296718B1 (fr) 2008-05-27 2009-04-24 Phosphate de calcium enrobant du ti6al4v avec une solution de liquide corporel tamponnée avec du lactate de sodium et de l' acide lactique

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TR2008/03782A TR200803782A2 (tr) 2008-05-27 2008-05-27 Modifiye edilmiş biyomimetik teknik kullanılarak kalsiyum fosfat esaslı kaplamaların yeni bir yaklaşımla sentezlenmesi.
TR2008/03782 2008-05-27

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3473277A1 (fr) * 2017-10-20 2019-04-24 Paul Scherrer Institut Procédé de croissance biomimétique de céramiques de phosphates de calcium sur des implants métalliques
CN115137875A (zh) * 2021-03-29 2022-10-04 杭州彗搏科技有限公司 一种高效的双相磷酸钙涂层方法

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10537661B2 (en) 2017-03-28 2020-01-21 DePuy Synthes Products, Inc. Orthopedic implant having a crystalline calcium phosphate coating and methods for making the same
US10537658B2 (en) 2017-03-28 2020-01-21 DePuy Synthes Products, Inc. Orthopedic implant having a crystalline gallium-containing hydroxyapatite coating and methods for making the same

Citations (1)

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EP1348452A1 (fr) 2002-03-29 2003-10-01 Depuy Products, Inc. Implants vertébraux avec une surface minéralisée

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EP1348452A1 (fr) 2002-03-29 2003-10-01 Depuy Products, Inc. Implants vertébraux avec une surface minéralisée

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3473277A1 (fr) * 2017-10-20 2019-04-24 Paul Scherrer Institut Procédé de croissance biomimétique de céramiques de phosphates de calcium sur des implants métalliques
WO2019076603A1 (fr) * 2017-10-20 2019-04-25 Paul Scherrer Institut Procédé de croissance biomimétique de céramiques de phosphate de calcium sur des implants métalliques
CN115137875A (zh) * 2021-03-29 2022-10-04 杭州彗搏科技有限公司 一种高效的双相磷酸钙涂层方法
CN115137875B (zh) * 2021-03-29 2023-06-13 杭州彗搏科技有限公司 一种高效的双相磷酸钙涂层方法

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TR200803782A2 (tr) 2009-06-22
WO2009145741A3 (fr) 2010-09-16
EP2296718A2 (fr) 2011-03-23
EP2296718B1 (fr) 2013-03-27

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